Galmed Pharmaceuticals (GLMD) 9 Aug 212021 Q2 Earnings call transcript

Good day and welcome to Galmed conference call to discuss financial results for the second quarter 2021. Today's conference is being recorded.

Before we begin, please note that we will be making certain forward-looking statements on today's call, including those regarding financial results, statements and forecasts regarding anticipated timelines and expectations with respect to our regulatory and clinical development programs as well as other statements that relate to future events. These statements are based on the beliefs and the expectations of the management of today and actual results, trends, timelines or projections in relation to our financial position and projected development program and pipeline could differ materially. We urge all investors to read carefully the risks and uncertainties disclosed in our filings with the SEC, including, without limitation, the risks under the heading Risk Factors described in our Annual Report on Form 20-F filed with the SEC and the risks and uncertainties included in the Form 6 K. earlier SEC the with today. filed obligation Galmed statements only. any looking update information assumes which dates no or respective speak forward their to as of would to conference Chief turn like Officer. Baharaff, Executive President and I over now to Allen the Allen, please go ahead.

as and Emma. to joining pleased us you you Liat today here with conference Thank Scientific thank I Hayardeny Officer, our today's Dr. call. for Yohai morning Stenzler Good am the be on our to provide out as an Chief and on with you on programs XXXX. second for Officer, you clinical update our development Financial well of results reporter to Chief financial quarter

As always, of you conclusion our questions we prepared remarks. any will happy take have the to may at be

can week Aramchol with plan the Let news with with Aramchol our without in or essence, me that meglumine with repeat Phase start any proposed the a clinical placebo-controlled of FDA this lieu proceed in nonclinical X studies. studies to we clinical free our announcing part use need that randomized earlier meglumine the to double-blind reported agreed FDA study. of the ARMOR In agreement acid we Aramchol

may recall, the exposure after administration daily currently XXXmg corresponds dosage is being Aramchol with existing ARMOR of administration Aramchol obtained the systemic daily that acid. study. Aramchol meglumine Phase twice which X dosing (BID) Aramchol compared doubled with Thus, evaluated free form oral meglumine of of Aramchol free once you XXXmg As in (QD) the to acid that

meaningful benefit the our to ways. IP two XXXX, until meglumine longer protection will its to As in in transition addition a reminder, December patients Aramchol

move we our a regimen in with and potential to registrational XX% The in less first, with once-daily required achieving API back X adherence means convenience part. improvement that Phase the can exposure

potentially as drug is the treatment, the significant form, developing consider potential transition of let our dose our via part treatment optimization, a NASH allows label our be validation meglumine Now FDA can XX i.e. given in agreement Aramchol and consistent weeks which efforts XX% The on final XX, reduce The marketing of Aramchol the included once approved a of potential open saving the you we and step and ARMOR optimization, longer cost treatment. product QB which goods. in patent optimization, significantly target higher We sole Aramchol study. optimization duration our compound the Phase is me XX to maximize of price can is approximately exposure X update that second and benefit, of to of of protection

ARMOR open As noninvasive us part in completed treatment XX available expected at of from our Results open label has one-third post-baseline the the are associated study that plan increasing and aimed as ARMOR you ARMOR the label at of potential highly of subjects, on techniques planned. valuable to may of Aramchol's XXXX X refistrational study success probability of approximately the the Phase biopsy QX be the study. recall, clinical of and fibrosis. duration population, liver This the about provide while is part NAST part derisking our with optimization development will data

Now shifting gear pipeline Amilo-XMER. our to compound,

a the specific In Aggregated Amilo-XMER A, code I dosing. of first-in-human this A. inflammation in pre-clinical are in quarter. is targeted in the being secretion. report happy Serum use. Amyloid Polymerization we later topline and As activity QX, Amilo-XMER Phase announced of first all X cytokines expected chronic aggregation, cytokine used pro-inflammatory essential mode currently Serum action. with Amyloid which a Earlier the of to potent multiple we in the completed for highly dosing demonstrated pro-inflammatory development unique inflammation. mechanism multiple to has is Phase and trials reminder, for action currently into am single a under and down-regulates clinical IBD a brief upstream serums, inhibitor production, and Amilo-XMER for and to the clinical chronic data and studies, X of trial Amilo-XMER of A main is dosing Amyloid which is biomarker with today, Amilo-XMER Serum of that you for clinical

accordingly. Amilo-XMER We inflammatory additional are mechanism currently diseases, relevant to looking at oral are developing moderate mild action developing other Since indication as are treatment an currently colitis. we chronic is of also its for formulations ulcerative and to

Before attend to investor's I are that we know conclude, like conferences three planning to the quarter. you I virtually in would coming

August Conference on XX to next to be The held Growth first XXXX. Canaccord XX, week is Annual

on is to the Cantor Conference be XXXX. Conference Annual Investor XXXX. held XX, XX, to Global to The September HC And second XX September Global on Healthcare held Wainwright XX the to be lastly,

We one-on-one will meetings during events. be these happy schedule to

transfer Now call let to me the CFO, Yohai our Stenzler.

second our Good morning, results Allen. with quarter XX, you June and be Thank I you This today. call morning the our financial for thanks ended joining providing XXXX. for would

results. to earlier please report information, on today our more summary financial provides X-K with other refer of Form among which, SEC such the filed a For things,

our development For clinical share, net resulted the $X.X compares million of, increase quarter primarily $X of a XXXX. The totaled million share to loss second ARMOR of the quarter expenses an the loss second connection quarter XXXX,. for with $X.XX increase for $X million trial. or XXXX, $X.X for XXXX. Research million expenses in with the with trial net from in the second This totaled compared second in quarter in per and per or $X.XX

Turning now to G&A.

in increase increase administrative in our quarter the and salaries insurance cost well totaled policy premium and in of from corresponding primarily as from The for the benefits. increase general an expenses D&O compared million as $X.X million $X.X resulted with period the Our for XXXX.

call. XX, million $XX.X as million With our of and balance said, instructions cash, June that restricted the Q&A provide operator, of cash totaled deposits equivalents, XXXX. term Our with which December includes cash XXXX marketable XX, $XX on for compared portion please securities cash, short

[Operator Instructions].

Canaccord from take now first our Genuity. with will go We Edward ahead. Nash question Please

is line Your open.

guys congratulations a and much That's ahead I with very getting go know. meglumine. the plus Aramchol you in huge you guys, for Thank Great.

the on So just be I in understand patients correct? we of XX next those this Is weeks? patients Phase to that design, correct? And I wanted getting first to then be year. fourth for the again, Is And X will review Those week. to you XX, will going be XX the next are XX the that XX quarter understand just but wanted XX? and thank the the that

not both three No. groups. correct. into morning. is patients No, Hi. blinded Good patient, are mean the the randomized I this

are half are So the that in this first XX biopsies. them of going be XX weeks These operations from and XX blind will part. have week the about rest double transitioned to we XX patients, and

Got it.

Okay..

and each of of So XX and XX, populations group mix is XX. the blinded XX

Perfect. Got it.

it powering forward approval all in that analysis, will Obviously the meglumine. obviously be and clearly, still give where Okay. the submission, Great. then And but only this Correct? front you will additional using be from accelerated FDA. apart data for for go of blind will the that the Aramchol from, safety you

Indeed. Yes.

know, So as the kinetics. about study efficacy is you

support the One, our for using are We safety which study reasons. NDA. already the really for of data main safety,

is powered of learn to based study study. an since higher, And Xb powering treatment is a there XX, the compare, initially to the there or association what and is optimal it's the thirdly is difference dose if if study was the on the duration, XX, ARMOR whether the is Second Phase is between XX two. much

twice exposure. is giving are we XX Now which daily, percent higher

are will accordingly. and the the of and accordingly of effect patients hence that change the We the expecting size powering change number study will

guys Perfect. much. so Thank you

you. Thank

you. Thank

Kluska from from question will Kristen take ahead. Cantor our now next We please go Fitzgerald.

line Your open. is

let and Hi. Allen the my congratulations also and outcome my Good on recent morning the for team. questions you this me meeting with taking to of add Thanks FDA.

is the more limited timing us pharmacology still you here? to studies start the and of could good a point next the time whether think I first around the First, ask planned to details wanted And of trial? if quarter end you provide with associated XXXX

I So take let Good Thank that. will Hello you. morning. Kristen. Liat

far are very reasonable FDA studies. Hi clinical offered the pharmacology three How Kristen. So doing? as you as we

to The first range one does is going with finding. do

finding which higher will by than Aramchol the match XXX twice as do is dose we alluded, And range the has, the dose relevant XXXmg exposure of twice milligrams Our XX% that daily exactly daily ARREST. have we Allen to acid. exposure

that food final is was This one effects. availability which quite is And the The the of clear. second offered bioequivalence is, we not study liked.

when So match is effects food the it's another just you to have transfer just new. currently a you daily, the regular, and which match to twice one from expect entity one when you dose it with through exposure, exposure and the do

further we quite a the is package, other regulators it's pharmacology fully the by which did development. thus has all regular So it acknowledged and far for clinical

the on it Now, very as question the dependent to timelines, is your formulation. about much

data the, relevant I set We ready. protocol better are allow of All year design at the that get end to study. of analysis is as data, before, very of the powering and should and amendments the we And decide the this and on plan statistical duration us the the said ready.

why on the initiate of formulation meglumine. order blind study time is to double this done the Aramchol is and the So produce with CMO to everything part in the with

the moment, once immediately with the about, and guidance the the initiate had FDA, at our product formulation. So discussions are we we drug process we to guidance received complete manufacturer the still from clear

formulation we QX, keep know have any QX we visibility if click delays. from to you be the will updated it development. only would would Whether there We into as more once would

about that. future particularly you some And green it Thanks. to ASCXX, I use study have official the in combinations that getting it will you potentially well? relates to here And multiple your now backbone. meglumine the agency, fourth this ongoing future light of the comments the therapy that combination here as forward appreciate But plans just determine it the as here? relates, a with a you then as look relates as also you data the from collaborations, we might how help past made quarter to are different of types your in evaluating as have in using

from now mean onwards, I meglumine. are using Absolutely. we Aramchol

product And the whether would or the open then our be it all this have that be communicated So the product Aramchol And that incorporate I that microbiome Aramchol be to the are this ASCXX or first all is forward. improved of of quarter by patients we done with will meglumine. study. an combination It's done already would in plan benefit meglumine in have XXXX. hope like we first the studies others improved other to label end This and together are from be to product. we taking and we going

last I Thanks. my then for that. appreciate you. Okay. And question

place pursue portfolio again. look because that now Now partners opportunity whether IP agreement in how would in you Specifically, Thanks strengthened? to the extended might an think commercialize? that is have changed this IP again to you geographies this portfolio, has and about certain you the has

Yes.

we that assumption We developing and have the Phase are always and working said, X. we are into it Aramchol openly meglumine under taking

Our geographical, And for are we any collaboration. looking door open. form is definitely of global, joint venture,

companies package API did in think their XX countries, than heavy agreements China, we very from have product. have pharmaceutical Brazil at of all on I from nice because I optimized to the continents. that data five for Korea, job East, of were around Middle lifting whatever. Australia that with the look would the getting U.S, all more built way the sites the one at mean the a we drug XXX course, globe, to around hand, we the terms regulation the and We any looking

review everyone you fine opportunity want hand that very to So giving is And and on sure to part, with their initiate a we hand one to double their optimization influence of they that. the the drug make lifting tuning. other because are blind an adjustments on before product all and own open to and the heavy the protocol partner I am wants together make the to this

we So commercial start study, open between any for are blind and of double discussion part today until we for the the discussion.

Thank you.

our next James. go Seedhouse question Raymond from take Steve ahead. now from will We Please

line open. is Your

could would to Aramchol Yes. sure Hi. so just on make the for Seedhouse. This like for meglumine. also correctly, green on is Ivannikov, understood main to I Timur the Steve light a And you I congratulate you manufactured be you to study, a were see material before label randomized needing so Phase data. that's X talking some Aramchol about start obviously need gatekeeper back holding you you to also but

what is of study? about Thank benchmark would you you. just see to kind what data? randomized you data could can proceed a So need before of the for Sort with talk that you

you thank I important think because the this So a issue. very is for question

meglumine data is to target the this is competitive in very Galmed, at Aramchol and the of looking landscape the at Here development we as what only are our in on the product profile data not ensure And our is data in well. we carefully, line that line in space. data, have of

recent datas studies study, that compounds NASH very it's resolution the a NASH and effect have resolution. or We significant NASH other on whether very semaglutide of are much aware

that on On the effect hand, acid. mild other obeticholic observe will the we very fibrosis from

So altogether, we package. best to trying the are give

the benefit label the the will our kind With open study. that Maybe see or first resolution, package, we will for XX wait to to safety. that from improvement need and is enough. give fibrosis patients XXX NASH this the patients will anticipate data we best is not to XXX. of Maybe precious the the be both the And

definitely embark and hoping or This and on, the have investors strong this first and study, signal, we sure think will probability have we X is initiating make to we see want decide say few another XX that. study, on derisked the double Phase all enough another we of we double are we we route part and to will look I will the We significantly that part patients. signal, program our study, because until quarters XXX of to blind extensive the the of with blind we a of this increase will patients the into the to responsibility data there be wait we then go success. quarter large we that and do that want at once patients But

to I think cross. planned that the we two

meglumine, we we to So it developed Aramchol formulation. gave

Aramchol Phase good X probably have kinetics very will regulatory the cross. arrive kinetics have the meglumine. will would that trial, Aramchol meglumine, We you have data the clinical that stability date are everything approximately formulation, design And and we the classical same best we with we at that the a somehow doing the time, will final trial. for on And And time, the so at from finally efficacy. full, of will formulation

remember, talk you every Okay. is the Thank still will timing saying I if Thank am you I months. six your also additional of And mid you cohorts around study? can next think about data that or the I be label you. for from that. cadence XXXX open sure different? not were cohort

No. The the XXXX. cohort quarter This is by of second correct. is anticipated

the XXX this So patients.

and another then by XX first the So XX mid XXXX.

one then question Amilo-XMER. another Okay. Great. And for

So about, for Phase minimally absorbed. oral only, think about just to distributed I in terms talked Xb oral right? of your indications. after and subcu clarify, still for oral Ia, you formulation, you just talk different going versus systemically Phase that's Can And

the we done And So Xa with Phase formulations. types and two subcutaneous was of volunteers. healthy now are working on

for We are is working ulcerative on formulation GI colitis for oral local the tract. which

formulation we joint. ulcerative talk same Xa at for are we effect to the the to injectable other too right about. a be the be tract. in where This in indication. with But create This open At also will So we is and This it probably and a RA, formulation, which formulation with it's we for injectable for local want again time, designed the early to GI place would also working to may Phase study colitis specific but be patients. working different are localized a will formulation. look the indications,

very much. Thanks Okay.

Thank you.

will Thank call. our complete remarks. turn back Allen you. Q&A Baharaff will for for call I section That now to any the closing today's

quarter will questions view of we and coming time to and So in more this meet submitted hope additional as you like we Canaccord to thank Cantor call Conference, study. hat number in part and which much also in welcome able conferences, Again, some Thank accepted see reiterate joining Annual we participation of the would very abstracts level you. the course course our to probably would hope catalyst be good news an would to Wainwright where I of which this will open Growth many of AASLD to and the at virtually with any and at this today. Conference a for be this have activity. for be our I that come three our we Conference communicate that you like hope of HC all eventually

Ladies and today's conference. gentlemen, that will conclude

all now disconnect. may You